Zanidatamab Combined With Chemotherapy as Neoadjuvant Therapy for HER2-high Expression G/GEJC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zanidatamab Combined with Chemotherapy.
- Who it may be relevant to
- Registry conditions: Gastric/Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Clinical Study of Zanidatamab Combined With Chemotherapy as Neoadjuvant Therapy for Locally Advanced HER2-high Expression (IHC3+/2+FISH+) Gastric/Gastroesophageal Junction Adenocarcinoma
Overview
HER2 overexpression is observed in approximately 20% of gastric cancers and gastroesophageal junction (GEJ) cancers, making it a validated target for anti-tumor therapy . In advanced-stage systemic therapy, trastuzumab combined with chemotherapy has demonstrated clinical benefits for HER2-positive gastric and GEJ cancers . However, the combination of trastuzumab and pertuzumab plus chemotherapy did not significantly improve overall survival (OS) compared to trastuzumab monotherapy in HER2-expressed gastric/GEJ cancers . In neoadjuvant therapy for early-stage or locally advanced gastric cancer, there is currently no standardized perioperative regimen for HER2-positive gastric or GEJ cancers, and effective treatment remains challenging . Zanidatamab, a humanized bispecific IgG1-like antibody targeting HER2's ECD4 and ECD2 epitopes, exhibits unique enhanced functionality . Phase II studies (NCT03929666) showed that zanidatamab combined with chemotherapy as first-line therapy for HER2-positive advanced gastroesophageal adenocarcinoma (GEA) demonstrated superior survival benefits and durable responses compared to standard therapy (trastuzumab plus chemotherapy) . A Phase III study (HERIZON-GEA-01, NCT05152147) is now underway to further validate its efficacy when combined with chemotherapy ± tislelizumab versus trastuzumab-based chemotherapy . For previously untreated stage II/III locally advanced gastroesophageal junction adenocarcinoma (cT1-2N+M0, cT3-4aNanyM0) with confirmed HER2 high expression (HER2 3+/2+ FISH+), neoadjuvant zanidatamab combined with chemotherapy (FLOT/SOX/CAPOX) is being explored to evaluate safety and efficacy, potentially offering a new treatment option for HER2-positive GEJ cancers in perioperative settings .
Interventions
- Drug Zanidatamab Combined with Chemotherapy
Zanidatamab Combined with Chemotherapy as Neoadjuvant Therapy
Primary outcome measures
- Major pathological response rate (MPR) [Time frame: 24 months]
Secondary outcome measures (4)
- Pathological complete response rate(pCR) [Time frame: 24 months]
- R0 Resection [Time frame: 24 months]
- Recurrence Free Survival (RFS) [Time frame: 5 years]
- Treatment-Emergent Adverse Events [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Signed informed consent.
- Histologically/radiologically confirmed Stage II/III (cT1-2N+M0 or cT3-4aNanyM0) Siewert II/III GEJ/gastric adenocarcinoma.
- HER2-high (IHC 3+/2+FISH+); HER2 2+ requires FISH (no time restriction).
- Age 18-75, any gender.
- ECOG 0-1, surgically eligible.
- Adequate organ function for abdominal surgery.
- Life expectancy ≥3 months.
Exclusion criteria
Exclusion criteria
- Unresectable/metastatic (Stage IV) disease.
- Prior systemic GC therapy.
- Other malignancies within 5 years (except those with >90% 5-year survival).
- Cardiopulmonary dysfunction.
- Major surgery within 4 weeks pre-study.
- Severe infection within 4 weeks.
- Prior chemo/targeted therapy.
- Hypersensitivity to study drugs/excipients/mAbs.
- Factors impairing oral intake (e.g., ≥Grade 2 dysphagia/chronic diarrhea).
- Uncontrolled comorbidities affecting compliance/outcomes.
- Pregnancy/lactation/planned pregnancy.
- Immunosuppression (>10mg/day prednisone equivalent within 2 weeks).
- Active HBV (DNA ≥1×10³ copies/mL or ≥200IU/mL), HCV+, or HIV+.
- Other antitumor trials within 28 days.
- Other high-risk conditions (e.g., psychiatric disorders) per investigator.
- Refusal to sign consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07273981 · XJ-G/GEJC-01